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tenofovir disoproxil orotate (Virreal)

✓ Approved

Dong-A ST · · 小分子

什么是 tenofovir disoproxil orotate？

tenofovir disoproxil orotate 是一种小分子，由Dong-A ST研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Virreal
公司Dong-A ST
药物类别小分子
分子靶点,
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Dong-A ST

作用机制

分子靶点

tenofovir disoproxil orotate 作用于 2 个分子靶点：

gag-pol, HIV-1 (gag-pol)
(P)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

tenofovir disoproxil orotate 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsAcquired immunodeficiency syndrome✓ Approved
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedInfectious diseases (London, England)2026-08-04

Clinical and virological characteristics of hepatitis B virus genotype E infection: a case series.

Tiecco Giorgio G, De Francesco Maria Antonia MA, Zeneli Laert L, Gottardi Federica F et al.

Hepatitis B virus (HBV) genotype E, mainly found in sub-Saharan Africa, exhibits low genetic diversity, unique molecular markers and high recombination potential but remains under-studied. This study describes the clinical and virological characteristics, mutational profiles, antiviral treatment responses and phylogenetic data of patients with confirmed HBV genotype E infection in a tertiary-care centre in northern Italy. A retrospective monocentric study was conducted at ASST Spedali Civili di Brescia, Italy, from 2015 to 2023. Patients with documented HBV genotype E who underwent genotypic resistance testing (GRT) for clinical reasons were included. Direct sequencing of the S/POL region was used for genotyping and mutation analysis, interpreted via Geno2pheno [hbv] 2.0 and Stanford HBV resistance tools. Eight patients were identified, mostly male (62.5%) and of African origin (87.5%), with a median age of 38.5 years. GRT was performed in six (75%) patients because of persistent viremia despite antiviral treatment, five (83.3%) of whom were HIV/HBV coinfected with detectable HIV viral load. Lamivudine resistance mutations (L180M, M204V) were found in one (12.5%) case, tenofovir resistance-associated mutations (M267L/I) in two (25%) and immune escape mutations in three (37.5%), including T126I, D144E and G145R. Despite GRT, treatment was not modified in four (50%) patients due to poor adherence concerns. Therapy adjustments led to viral suppression in three (37.5%) cases. In our setting, HBV genotype E infections largely occurred among migrants from endemic regions. Although nucleos(t)ide analogues are effective across genotypes, suboptimal adherence may hinder viral suppression and promote resistance.

PMID 42547309
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PubMedThe Journal of the Association of Physicians of India2026-08-03

Antiretroviral Therapy in India (2025): Drugs, Indications, Contraindications, Mechanisms, and Prophylaxis (PEP/PrEP).

Deshwal Rajesh R

India has made major gains in HIV control, with nationwide scale-up of antiretroviral therapy (ART), routine viral load monitoring, and simplified dolutegravir-based regimens. Yet gaps persist in differentiated service delivery, drug-resistance surveillance, and prevention implementation (PEP/PrEP). To provide a comprehensive, India-focused review of currently available antiretroviral drugs and fixed-dose combinations (FDCs), indications and contraindications for ART initiation, core mechanisms of action by class, regimen selection and monitoring, and detailed, practical guidance on HIV postexposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP), with attention to 2024-2025 updates. Narrative review of national guidance (NACO), WHO recommendations, and key implementation documents and peer-reviewed Indian literature (2018-2025), emphasizing policy-relevant updates and practical algorithms. (1) First-line ART in India is an FDC of tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD), with alternatives guided by renal, hepatic, pregnancy, TB cotreatment, and toxicity considerations. Viral load monitoring and "Treat All" remain policy cornerstones. (2) PEP: NACO's national PEP document continues to list a 28-day triple regimen with TDF + 3TC + EFV started as soon as possible (preferably ≤2 h; within 72 h). Several institutions have operationalized DTG-based PEP (TDF/3TC/DTG) in line with broader ART updates and WHO's 2024 PEP guidance favoring 3-drug regimens. (3) PrEP in India: DCGI approved TDF/FTC for PrEP; national technical guidance exists, but programmatic rollout remains uneven. Global prevention options expanded with FDA approval (June 2025) of twice-yearly injectable lenacapavir for PrEP. Indian availability will depend on future regulatory decisions and access arrangements. India's ART platform is strong and increasingly INSTI-based. Scaling PrEP, standardizing DTG-aligned PEP, fortifying viral load and resistance monitoring, and integrating long-acting prevention as it becomes available are the next priorities.

PMID 42543939
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PubMedCureus2026-08-03

Dolutegravir-Associated Dyslipidemia and Atherogenic Lipid Changes Among Treatment-Naïve People Living With HIV: A 12-Month Prospective Cohort Study From Southern India.

Sebastian Savitha A SA, Devasia Cerin C, Selvam Sumithra S, Idiculla Jyothi J

Background Dolutegravir (DTG)-based antiretroviral therapy (ART) is widely used for the treatment of people living with HIV (PLHIV). As cardiovascular disease risk becomes increasingly important in the long-term management of PLHIV, understanding changes in lipid parameters following initiation of DTG-based therapy is clinically relevant. Prospective data on dyslipidemia and atherogenic lipid indices among Indian PLHIV initiating tenofovir disoproxil fumarate-lamivudine-dolutegravir (TLD) remain limited. This study aimed to evaluate changes in lipid profiles and atherogenic indices over 12 months among ART-naïve PLHIV initiating TLD. Methodology We conducted a 12-month prospective cohort study at the HIV Clinic of a tertiary teaching hospital in Bengaluru, India. A total of 70 adult ART-naïve PLHIV initiating TLD were enrolled consecutively. Participants with baseline dyslipidemia, lipid-lowering therapy, pregnancy, or lactation were excluded. Fasting lipid profile, including serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides (TG), and atherogenic indices (TC/HDL-c ratio, TG/HDL-c ratio, non-HDL cholesterol) were measured at baseline and 12 months. Body mass index (BMI), fasting blood sugar (FBS), serum alanine aminotransferase (ALT), and serum creatinine were also recorded at these time points. Enrolled participants were followed up for 12 months to determine the one-year incidence of dyslipidemia and changes in lipid parameters and atherogenic indices. Results All 70 participants completed follow-up (100% retention; median age = 33 years (interquartile range = 27-40); 74.3% male). The main finding was that 24/70 (34.29%, 95% confidence interval = 23.5-46.7) developed incident dyslipidemia at 12 months, with 17/24 (70.8%) demonstrating ≥2 concurrent lipid abnormalities. Low HDL-c (24.29%) and hypertriglyceridemia (22.86%) were most frequent. Statistically significant adverse mean changes occurred in TC (157.1 → 164.6 mg/dL; t(69) = 2.23, p = 0.029), LDL-c (95.8 → 111.1 mg/dL; t(69) = 5.15, p < 0.001), TG (131.7 → 154.7 mg/dL; Z = 3.60, p < 0.001), non-HDL-c (108.9 → 119.8 mg/dL; Z = 2.45, p = 0.014), TC/HDL-c ratio (3.37 → 4.03; Z = 2.18, p = 0.029), and TG/HDL-c ratio (2.85 → 4.04; Z = 3.05, p = 0.002). HDL-c declined non-significantly (48.2 → 44.8 mg/dL; t(69) = -1.83, p = 0.071). BMI rose +0.67 kg/m² (t(69) = 3.43, p = 0.001), serum creatinine +0.11 mg/dL (t(69) = 4.86, p < 0.001), ALT increased by 12.6 IU/L (Z = -5.97, p < 0.001), and FBS +7.6 mg/dL (t(69) = 2.00, p = 0.049), without new diabetes. Conclusions DTG-based antiretroviral therapy (TLD) was associated with a 34.29% one-year incidence of dyslipidemia in ART-naïve Indian PLHIV, with significant adverse shifts in atherogenic indices. These findings support routine lipid and metabolic surveillance and consideration of statin therapy in eligible patients as essential components of monitoring care for PLHIV on DTG-based ART.

PMID 42544255
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PubMedDialogues in health2026-08-02

Rapid cross-sectional impact assessment of an earthquake on the continuity of antenatal care for pregnant women living with hepatitis B in Vanuatu.

Bell Leila L, Kalulu Aleesha A, Allard Nicole N, Ameara Kali K et al.

Natural disasters such as earthquakes, cyclones, and volcanic eruptions directly and indirectly impact health and wellbeing. This work aimed to understand how access to, and use of, peripartum health services were impacted following a large 7.3 magnitude earthquake in Vanuatu in the context of an ongoing field trial looking at the effectiveness of universal peripartum antiviral prophylaxis for pregnant women living with hepatitis B to prevent mother-to-child transmission. Participants were pregnant women enrolled in the intervention-arm of a field trial at sites in the earthquake-affected area. During routine monitoring calls, we asked additional questions about the impact of the earthquake on continued access to health services and continued use of daily hepatitis B antiviral prophylaxis with tenofovir disoproxil fumarate. Seventeen participants of 26 women enrolled in the trial could be contacted and answered all questions from early-February to early-March 2025. Self-reported continued use of tenofovir disoproxil fumarate was high, with only two of 17 participants reporting interruptions to use in the weeks following the earthquake. Seven participants (41%) reported missing at least one routine antenatal or postnatal appointment in the three months following the earthquake. In natural disaster-prone settings, it is critical that field research take an adaptive approach that can adjust and respond to health emergencies. While natural disasters are inevitable, health systems must implement risk mitigation strategies to limit interruptions to routine health services to reduce negative short-, medium-, and long-term health impacts of natural disasters.

PMID 42542601
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PubMedEClinicalMedicine2026-08-02

Hepatitis B virus outcomes in people with HIV after cessation of tenofovir-containing antiretroviral therapy: a systematic review and meta-analysis.

Mohareb Amir M AM, Phinius Bonolo B, Anderson Motswedi M, Lockman Shahin S et al.

Antiretroviral therapy (ART) regimens without tenofovir have risks related to hepatitis B virus (HBV). As these regimens are being used more frequently, clinicians and policy makers would benefit from an accurate estimate of the risk of HBV outcomes following tenofovir cessation. We conducted a systematic review of HBV reactivation and infection in people with HIV who discontinue tenofovir. We searched Medline, Embase, Google Scholar, and the Cochrane database (1 January 2006-15 February 2026) for studies related to tenofovir cessation in people with HIV and (1) active HBV: positive HBV surface antigen (HBsAg); (2) resolved HBV: positive HBV core antibody (HBcAb) without HBsAg; and (3) susceptibility to HBV: negative HBsAg, HBcAb, and HBV surface antibody. We used a random effects model to calculate the pooled incidence rate of HBV reactivation (in resolved HBV) and new HBV infection (in those susceptible to HBV) after tenofovir cessation. We used multivariable meta-regression to compare pooled outcomes across subgroups. We used I2 to assess inter-study heterogeneity, and we tested for publication bias using Egger's test. This review is registered with Prospero (#2025-CRD420251080460). Of 144 abstracts and articles, 53 underwent full-text review, and 22 unique observational studies were included. In eight studies of active HBV infection, only descriptive data could be retrieved without a meta-analysis: HBV DNA increase or hepatitis flares commonly occurred in most studies after tenofovir cessation or interruption. In six observational studies of resolved HBV infection with active surveillance of HBV serological markers after tenofovir cessation, pooled incidence of HBV reactivation was 3.79/100 person-years (95% CI 1.98-7.23; I2 = 57.6%; moderate certainty). This was higher than the pooled incidence in studies without active monitoring for HBV reactivation (0.35/100 person-years, 95% CI 0.12-1.03; p < 0.001). Six observational studies reported new HBV infections in susceptible people following transition to tenofovir-sparing ART (pooled incidence = 1.63/100 person-years, 95%CI = 0.27-9.92; I2 = 78.6%; very low certainty). Egger's test showed no statistically significant evidence of publication bias (p = 0.216). In people with HIV, tenofovir-sparing ART is associated with risks related to HBV reactivation and infection. Higher quality prospective studies are needed in people with HIV who stop tenofovir. National Institutes of Health and Harvard University Center for AIDS Research.

PMID 42541296
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PubMedExperimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation2026-08-01

Hepatitis B Reactivation After Kidney Transplantation in Hepatitis B Surface Antigen-Positive Recipients.

Tatar Bengü B, Uslu Adam A, Arı Alpay A, Kavak Selçuk S et al.

Hepatitis B virus reactivation in HBsAg -positive kidney transplant recipients sometimes results in liver failure and death. Although current guidelines recommend continuing antiviral therapy for ≥6 months after the last dose of immunosuppressive therapy, in transplant recipients, duration is uncertain because immunosuppressive therapy is lifelong. Here, we evaluated the incidence and effects of hepatitis B virus reactivation in kidney transplant recipients with hepatitis B virus infection. We reviewed patients who underwent kidney transplant between 2012 and 2023; we excluded patients with missing hepatitis B serology, those who were hepatitis B surface antigen negative /anti -HBc negative, those with total follow -up of <1 year, and those with coinfection. Hepatitis B virus reactivation was defined as at least a 100 -fold increase in hepatis B virus DNA levels in patients with previously detectable or levels that were negative before becoming positive. In 21 hepatitis B surface antigen -positive kidney transplant recipients, mean age was 45.8 ± 8.5 years, 76 % were male, and 62 % had living donor transplant. Mean follow -up was 86 ± 32 months. Seven transplant recipients received antiviral treatment (3 with entecavir, 3 with tenofovir disoproxil fumarate, 1 with lamivudine ). Among 14 patients without antiviral treatment, 7 had positive HBV DNA ( >69 IU /mL ) at time of transplant All recipients received prophylactic antiviral therapy (14 received entecavir, 4 received lamivudine, 3 received tenofovir disoproxil fumarate ) concomitant with transplant. During follow -up, hepatitis B virus reactivation was observed in 25 % of patients who received lamivudine. No serious adverse outcomes, including liver transplant or death, due to HBV reactivation were observed. Although optimal duration of prophylactic antiviral therapy remains unclear, entecavir or tenofovir was the preferred antiviral therapy over lamivudine for hepatitis B virus reactivation prophylaxis. Close monitoring with antiviral prophylaxis is the optimal strategy to prevent hepatitis B virus reactivation during immunosuppressive therapy.

PMID 42538704
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